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An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075854
First received: February 24, 2010
Last updated: July 30, 2014
Last verified: September 2010
  Purpose

This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.


Condition Intervention
Multifollicular Stimulation
Drug: Gonal-F (Follitropin alfa)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Multi-center, Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to IVF/ICSI

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Start of treatment to confirmation of pregnancy ] [ Designated as safety issue: No ]
    Number of oocytes retrieved and clinical pregnancy rate per cycle


Secondary Outcome Measures:
  • Efficacy, Safety and Convenience [ Time Frame: Start of treatment to confirmation of pregnancy ] [ Designated as safety issue: Yes ]

    Secondary efficacy parameters includes total Gonal-f dose; stimulation profile of IVF cycle; number of follicles > 14 mm on day of hCG; number of available embryos; pregnancy status (hCG test, ultrasound exam); on the day of embryo transfer (ET).

    Convenience and safety parameters includes subject convenience rated by completing a questionnaire, local tolerance assessment (local reactions at the injection site, pain, satisfaction and convenience)



Biospecimen Retention:   Samples Without DNA

Serum samples


Enrollment: 1539
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gonal-F (Follitropin alfa)
    Follitropin alfa FbM solution for injection in a prefilled pen is available in three strengths: 300 IU/0.5 ml (22 µg/0.5 ml), 450 IU/0.75 ml (33 µg/0.75 ml) and 900 IU/1.5 ml (66 µg/1.5 ml). The starting dose is usually recommended to be between 150 and 300 IU. The dose is then adjusted according to the ovarian response.
    Other Name: Gonal-F
Detailed Description:

Follicle stimulating hormone (FSH) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. The technical advance of recombinant technology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. These developments have enabled recombinant human FSH follitropin alfa (Gonal-F) to be filled and released in vials on the basis of mass with a variability of only ±2%. In one study, the FbM batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. In another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. The authors concluded that the pen device of Gonal-F is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form.

This prospective, multicentric, observational study is planned in women using Gonal-F FbM in ovarian hyperstimulation as part of their IVF/ICSI treatment at infertility clinics in Korea. Subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects).

OBJECTIVES

Primary objective:

  • To assess the effectiveness Gonal-F FbM

Secondary objectives:

  • To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female subjects who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for the study.

Criteria

Inclusion Criteria:

  • Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study

Exclusion Criteria:

  • Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the excipients
  • Subjects with tumors of the hypothalamus and pituitary gland
  • Ovarian enlargement or cyst not due to polycystic ovarian disease
  • Gynecological hemorrhages of unknown etiology
  • Ovarian, uterine or mammary carcinoma
  • Primary ovarian failure
  • Malformations of sexual organs incompatible with pregnancy
  • Fibroid tumors of the uterus incompatible with pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075854

Locations
Korea, Republic of
Maria Fertility Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Head of Medical Department, Merck Serono Korea, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01075854     History of Changes
Other Study ID Numbers: EMR 700623_507
Study First Received: February 24, 2010
Last Updated: July 30, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck KGaA:
Gonal-F
Multifollicular stimulation
Pregnancy
Ovarian hyperstimulation
In vitro fertilization
Intracytoplasmic sperm injection
Infertility

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014